19 September 2024 Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved Fruzaqla (fruquintinib) to treat adults with metastatic colorectal cancer (CRC)—to be used when other treatments have not worked. 20 September 2024
Today, the US Food and Drug Administration approved Miplyffa (arimoclomol), an oral medication for the treatment of Neimann-Pick disease, type C (NPC). 20 September 2024
Danish drugmaker Novo Nordisk—a frontrunner in the obesity space with the GLP-1 receptor agonist Wegovy (semaglutide)—is now making swift progress in the field with monlunabant, a small molecule oral cannabinoid receptor 1 (CB1) inverse agonist. 20 September 2024
The European Medicines Agency’s (EMA) Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting 20 September 2024
Aligos Therapeutics (Nasdaq: ALGS) has announced positive top-line results from the Phase IIa HERALD study of ALG-055009, a thyroid hormone receptor beta (THR-β) agonist, in metabolic-dysfunction associated steatohepatitis (MASH) subjects. 20 September 2024
US neuroscience company BioXcel Therapeutics has announced a new clinical prioritization and an update on its late-stage development programs for the treatment of agitation with BXCL501. 20 September 2024
Sanofi has announced encouraging results from its Phase III HERCULES trial of tolebrutinib in people with non-relapsing secondary progressive multiple sclerosis (nrSPMS). 20 September 2024
The Israeli Ministry of Health (IL MOH) has approved Tevimbra (tislelizumab) as monotherapy for the treatment of adult patients with unresectable or metastatic oesophageal squamous cell carcinoma (OESCC). 20 September 2024
Basilea Pharmaceutica announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response (ASPR) has awarded Basilea an Other Transaction Agreement (OTA), under OTA number 75A50124C00033. 20 September 2024
Edgewise Therapeutics has announced promising top-line results for its candidate EDG-7500, aimed at treating hypertrophic cardiomyopathy (HCM). 20 September 2024
Achilles Therapeutics has announced it will discontinue its tumor-infiltrating lymphocyte (TIL)-based clonal neoantigen T cell (cNeT) program and shut down its Phase I/IIa CHIRON and THETIS trials. 20 September 2024
The European Medicines Agency’s (EMA) advisory committee the CHMP has adopted a positive opinion for a label update of Danish drugmaker Novo Nordisk’s Wegovy (semaglutide 2.4mg). 20 September 2024
US companies Incyte and Syndax Pharmaceuticals today announced results from the pivotal Phase II AGAVE-201 trial of Niktimvo (axatilimab-csfr), 19 September 2024
Vanda Pharmaceuticals’ shares were down more than 10% at $4.45 pre-market today, as the) company provided an unfavorable update on its tradipitant development program. 19 September 2024
Stalicla, a privately-held Swiss biotech, today announced that Dr Paulo Fontoura will be joining its drug development team as chief scientific and clinical development advisor. 19 September 2024
Shares of Seattle, USA-based biotech Alpine Immune Sciences 20% on a takeover rumor by Bloomberg, and leapt a further 36% pre-market to $64.10 when the speculation was confirmed. 11 April 2024
Data from the RESMAIN study of Kinselby (resminostat) have been presented at the 5th World Congress of Cutaneous Lymphomas (5WCCL), at the City of Hope, Pasadena, California, USA. 11 April 2024
The European Parliament has formally adopted new pharmaceutical legislation, including proposals for a new directive and a new regulation. 11 April 2024
US clinical-stage biotech Rallybio Corporation saw its shares leap 76% to $2.87 pre-market today, after it revealed a collaboration with healthcare giant Johnson & Johnson. 11 April 2024
The US Food and Drug Administration has given a green light to BrainStorm Cell Therapeutics for the design of a Phase IIIb trial of NurOwn (MSC-NTF cells). 10 April 2024
Los Angeles, USA-based TORL BioTherapeutics, a biotech focused on discovering and developing antibody-based immunotherapies, has closed an oversubscribed $158 million Series B-2 financing. 10 April 2024
Affecting one in 19 women, polycystic ovary syndrome (PCOS) remains understudied, with no dedicated treatments. Surprisingly, new diabetes and weight loss drugs may help. 10 April 2024
A private share placement is set to land Massachusetts, USA-based Acrivon Therapeutics with an additional $130 million to fund its oncology research. 10 April 2024
Keen to take French pharm major Sanofi head-on, the Serum Institute of India (SII) is to scale up supplies to fulfil India's entire annual demand for injectable inactivated poliomyelitis vaccines (IPV). 10 April 2024
Antibody drug conjugates (ADCs) are currently in vogue with investors and big pharma, as a rapidly emerging class of therapeutic agents that combine the target specificity of a monoclonal antibody with the lethality of cytotoxic cellular poison. 10 April 2024
Swiss ophthalmology firm Oculis Holding today announced the appointment of Dr Snehal Shah, executive leader with over two decades of research and development (R&D) and regulatory experience, to the role of president of R&D. 10 April 2024
Cell programming specialist Ginkgo Bioworks today announced the expansion of its strategic partnership with Denmark’s Novo Nordisk under a framework agreement that initially is contemplated to run over five years. 10 April 2024
There has been an uptick in licensing agreements for drugs incorporating clustered regularly interspaced short palindromic repeats (CRISPR)-based technology over the past five years, notes GlobalData. 10 April 2024
Japan-based Teijin Group’s healthcare business, Teijin Pharma, has entered into an exclusive global licensing agreement with French drugmaker Bioprojet Pharma. 10 April 2024
British specialty medicines firm Essential Pharma has announced the completion of the acquisition of the entire issued share capital of fellow UK-based Renaissance Pharma. 10 April 2024
For the last three decades, the availability of cost-effective generic medicines has driven increased access to life-saving treatments for millions of patients in Europe. 10 April 2024